A Randomized Controlled Study of Different Trigger Modes of Antagonist Regimen in Patients With Low Ovarian Reserve

Not Applicable

• Conditions: Poor Ovarian Response
• Interventions: Drug: Ovidrel; Drug: Troprilin

• Registration Number: NCT04717752
• Lead Sponsor: Nanjing University

Brief Summary

Assisted reproductive technology (ART), especially controlled ovarian stimulation (COS), significantly increased clinical pregnancy rates among infertile patients. However, about 9% to 24% of patients had poor ovarian response to gonadotropins (GNS) stimulation, which was called poor ovarian response (POR). In recent years, the diagnosis and treatment of patients with low fertility is the challenge for reproductive medicine. To better demonstrate the effectiveness of various interventions and distinguish the different subgroups of patients, 2016 POSEIDON (Patient-Oriented Strategies Encompassing Individualized Oocyte Number) standard changed low reaction into low prognosis of patient-oriented individual strategies to obtain eggs. For patients in group 3 and group 4 classified by POSEIDON, ovarian reserve function decline, follicular development desynchrony and low numbers of oocytes obtained lead to poor prognosis. In 2020, the prognosis based on Delphi method of assisted reproductive technology to treat low crowd diagnosis expert opinion in China recommended to give these patients conventional cosine solutions such as antagonist. In the first cycle, follicle stimulating hormone (FSH) starting dose of 225 \~ 300 iu is suggested to achieve plenty of ovarian stimulation for standards and maximize the benefits of superovulation. Because of the particularity of luteal support in the antagonist regimen, it is of great clinical significance to explore the trigger mode and combination mode of luteal support in the antagonist regimen for patients with poor prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Study Start: 2021-01-20
• Study First Posted: 2021-01-22
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 310

Inclusion Criteria

• Age less than or equal to 42 years old, AFC<5 and or AMH<1.2ng/ml ② Adopt antagonist program for controlled ovulation hyperstimulation (COH); patients with fresh cycle transplantation;

  • Accept conventional IVF or intracytoplasmic sperm injection (ICSI);

    • The ART treatment cycle is less than 3 times.

Exclusion Criteria

• Abnormal chromosome karyotype;

  • Severe endometriosis;

    • Abnormal thyroid function; ④ Pregnancy contraindications; ⑤ Past history of ovarian tumors or after receiving radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double trigger unit	Troprilin	HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg
Double trigger unit	Ovidrel	HCG: 6000IU (Ovidrel: 250ug) + GnRH-a (Troprilin) 0.2mg
HCG trigger unit	Ovidrel	HCG: 6000IU (Ovidrel: 250ug)

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate in each transplantation cycle	6 weeks	number of pregnant cases are confirmed by ultrasound/ total number of transplanted

Secondary Outcome Measures

Name	Time	Method
Rate of cancelled cycle	6 weeks	number of cancelled cycles/ number of total cycles
Number of mature eggs	6 weeks	number of matured oocytes
Implantation rate	6 weeks	number of gestational sacs/ number of transplanted embryos
Number of high-quality embryos	6 weeks	number of D3 high quality embryos (≥7 scores)
Early abortion rate	6 weeks	number of miscarriage cases/ number of pregnant cases confirmed by ultrasound
Cumulative pregnancy rate per stimulation cycle	6 weeks	number of pregnant cases which are confirmed by ultrasound/ total number of stimulation cycle

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China